Recently, it has been reported that the monitoring of acidity or pH of a patient's breath could help physicians in estimating the degree of air passage inflammation, now considered a key contributor to asthma, LPR and other respiratory conditions. Asthma is characterized by symptoms of wheezing, coughing, chest tightness, and shortness of breath. Manifestations include constriction (the tightening of the muscles around the airways) and inflammation (the swelling and irritation of the airways) that can be triggered through exposure to smoking, dust mites, pets, activity, cold, infection, weather, pollen, etc.
A clinical study of people with chronic obstructive pulmonary disease (COPD), bronchiectasis and asthma demonstrated more acidic levels in COPD and bronchiectasis patients, which is indicative of the chronic inflammation that these patients experience. This study also observed an increased acidic level measured from the breath of patients suffering from moderate asthma when compared to mild forms of the disease. It was also found that the asthmatics' breath was much more acidic during asthma attacks, but normalized after anti-inflammatory medication was administered.
This data suggests that the monitoring of an asthmatic's breath for pH might be an effective way to measure the degree of inflammation in the air passages. Furthermore, this data suggests that close monitoring of an asthmatic's breath pH could lead to prompt and effective treatment, minimizing the occurrence of asthma attacks and providing overall better asthma management.
It is estimated that 18-26 million people in the United Stated suffer from asthmatic conditions ranking this disease as the 8th worst chronic condition in the US. It is also believed that over 5.6 million of these asthma sufferers are under the age of 18.
Studies have also shown that gastroesophageal reflux (GER) affects approximately 40% of the US adult population and that 60-80 percent of all asthma patients have GER. Gastro-esophageal reflux is a condition in which gastric acid refluxes from the stomach and into the esophagus. Frequent reflux episodes may result in a potentially severe problem known as gastroesophageal reflux disease (GERD). GER is the most common cause of dyspepsia or heartburn. GER can also manifest in the micro-aspiration of acid from the esophagus into the airway and lungs, damaging tissue, and causing irritation of the vagus nerve. This irritation of the vagus nerve, which is common to both the esophagus and the bronchial tree, can cause constriction of the airway. Acid reflux above the lower esophageal sphincter can cause anatomical damage and is linked to sleep disordered breathing. It has also been found that bronchial dilator drugs can relax the lower esophageal sphincter and trigger GERD induced asthmatic conditions. Sleep apnea has also been found to trigger reflux events. Testing for GER and the diagnosis of GERD are typically accomplished by measuring pH with catheter based devices.
These current pH monitoring methods suffer from the following drawbacks: 1) the current method requires an invasive procedure to place a pH measurement catheter or implanted pH measurement capsule in the patient's esophagus, 2) the procedure is not well tolerated by some patients, 3) the catheter or capsule placement must be performed by a physician, 4) the capsule cannot be placed above the Upper Esophageal Sphincter (UES) to measure airway pH, and 5) there are no defined standards for evaluation of pH above the UES.
Accordingly, there is a need in this art for a novel, pH diagnostic and monitoring system with electronic or wireless communication linked to a processing receiver that can also be used to activate a therapeutic nebulizer/atomizer/humidifier for treating asthmatic or other respiratory conditions.